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Safety and efficacy of insoluble (1,3)-(1,6)-beta-glucan made from brewers yeast (Saccharomyces cerevisiae)

Condition category

Infections and Infestations

Date applied

30/07/2012

Date assigned

03/08/2012

Last edited

05/10/2016

Prospective/Retrospective

Retrospectively registered

Overall trial status

Completed

Recruitment status

No longer recruiting

Plain English Summary

Background and study aimsBeta-glucans are sugars found in the cell walls of brewers’ yeast, fungi, and some bacteria. Due to its immune system stimulating properties, beta-glucan may have an effect on the incidence of common cold (a mild viral infection of the nose, throat, sinuses and upper airways). The aim of this study is to investigate the effectiveness and safety of the beta-glucan extract Yestimun® in people who are more susceptible to the common cold.

Who can participate? Healthy males and females aged 18-70 who have had at least three common cold infections within the last 6 months

What does the study involve? During the study period of 16 weeks, participants are randomly allocated to consume a capsule of either Yestimun or a placebo (dummy tablet) each with breakfast and supper. Participants attend three visits: at the start of the study, after 8 weeks and at the end after 16 weeks. The number, severity and duration of colds, use of antibiotics and analgesics (painkillers), and side effects are assessed in both groups.

What are the possible benefits and risks of participating? Participants may benefit from a reduced incidence of common cold, and there are no risks expected.

Where is the study run from? The study is conducted in seven study centres in Berlin, Germany

When is the study starting and how long is it expected to run for? October 2010 to May 2011

Who is funding the study? Leiber GmbH (Germany)

Who is the main contact? Dr Annegret Auingeraauinger@analyze-realize.com

Contact details

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Study information

Scientific title

Double-blind, randomized, placebo-controlled clinical study to evaluate efficacy and safety of Yestimun® in subjects with increased susceptibility to common cold

Acronym

Study hypothesis

Due to the immune-modulating properties of yeast beta-glucan, the number of common cold episodes is expected to be decreased during the study period in the verum study arm compared to the placebo study arm.

Primary study design

Secondary study design

Trial setting

Trial type

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Immune function

Intervention

Subjects were randomly assigned to receive a total of 900 mg of either Yestimun® or placebo, each provided in two capsules per day, which were consumed at breakfast and supper.

During the study period of 16 weeks, a total of three routine visits were performed: at baseline, after 8 weeks and at the end after 16 weeks. In addition, one episode visit was conducted on the 5th day of each cold episode.

A cold episode was defined by having (any of) the following symptoms: headache, joint pain, sore throat, difficulty swallowing, hoarseness, coughing, watery nasal discharge, nasal congestion, cold related sleeping difficulties, and body temperature above 38°C. During an episode, the subjects recorded and assessed their cold symptoms in the subject diary, for a period of 14 days. The diaries were checked by the investigators at the Episode Visits of each episode. At study end (Termination Visit), the investigators and the subjects assessed the global efficacy and tolerability of the investigational product. At the start and end of the study, subjects recorded their eating habits in a diet diary.

Intervention type

Drug

Phase

Not Applicable

Drug names

Yestimun®

Primary outcome measures

Reduction of number of cold episodes during the study period in the Yestimun® study arm compared to placebo study arm

Secondary outcome measures

1. Severity of cold episodes (total sum score during the entire episode)2. Duration of cold episodes (based on subject diary)3. Severity of colds at episode start (total score on day 1 and day 2)4. Severity of colds on the day of the Episode Visit (CRF)5. Use of antibiotics and analgesics (subject's diary)6. Global assessment of efficacy and tolerability7. Assessment of adverse events8. Assessment of sick leave days

Overall trial start date

15/10/2010

Overall trial end date

12/05/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age: ≥ 18 years (child-bearing females had to agree to use appropriate birth control methods)2. At least three common cold infections within the last six months3. Written consent of the subject to study participation, subject understands the requirements and is willing to comply

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

224

Participant exclusion criteria

1. Acute infection of the upper airways (e.g. acute bronchitis)2. Chronic upper airway disease (e.g. chronic bronchitis, tonsillitis or asthma)3. Chronic cough of any origin4. Chronic rhinitis (vasomotor or allergic rhinitis)5. Congenital or acquired immunodeficiency disease (e.g. HIV infection)6. Acute or chronic diarrhea7. Severe organ or systemic diseases8. Suspected swine flu or influenza9. Body temperature above 37.5°C10. Vaccination against influenza or swine flu within 21 days prior to study start11. Known hypersensitivity to ingredients of the investigational product12. Pregnancy and lactation13. Use of immunosuppressants14. Use of immunostimulants (e.g. Echinacea) within the last 14 days prior to study start15. Use of antibiotics within the last 14 days prior to study start16. Alcohol/drug abuse; drug addiction17. Simultaneous participation in another clinical trial or participation in a clinical trial within the last 4 weeks18. Regular use of other yeast preparations19. Incertainty regarding compliance